Respiratory PathogensRAPIDNCT03756753
The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
A study testing Results available to provider in people with Respiratory Pathogens and Upper Respiratory Tract Illness, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention group - results available to medical providers, or the control group- results not available to medical providers. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Respiratory Pathogens, Upper Respiratory Tract Illness, Lower Respiratory Tract Illness
- What is being tested?
- Results available to provider
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 913 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 1 month to < 18 years
- For children aged 1 month to 12 months of age: Presentation to the study sites with temperature > 37.8°C or cough, sore throat, runny nose or nasal congestion
- For children aged > 1 year to 18 years of age: Presentation to the study sites with influenza like illness, defined as temperature of >37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion
- Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)
Who cannot join
- Respiratory symptom duration > 14 days
- Previous enrollment in study within past 14 days
- Nurse-only visit
- Triage levels 1 and 2 based on Emergency Severity Index
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention group - results available to medical providers, or the control group- results not available to medical providers.
Read the detailed description
The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in children presenting to an Emergency Department setting with acute respiratory symptoms. The patient cohort will be children 1 month to 18 years of age presenting to the Children's Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population who are evaluated in an urgent care setting. All eligible participants will undergo a nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care). The investigators will compare the clinical outcomes between the two groups.
- Conditions
- Respiratory Pathogens, Upper Respiratory Tract Illness, Lower Respiratory Tract Illness, Acute Respiratory Infection
- Being tested
- Results available to provider
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Results available to providerDiagnostic test
Results of point of care testing are given to provider
| Study group | Role | What they receive |
|---|---|---|
| Intervention group- results known | Experimental | Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results Receives: Diagnostic Test: Results available to provider |
| Control group- results not known | No intervention | Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit
Proportion of children who are prescribed an antibiotic at the ED visit.
Measured: day 0
Secondary outcomes (7)
Proportion of children treated with influenza antiviral at the ED visit
Proportion of patients treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.
Measured: day 0
Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit
Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.
Measured: day 0
ED length of stay (hours)
Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.
Measured: day 0
Days of Hospitalization
Proportion of patients hospitalized within 10 days of enrollment in the study
Measured: day 0-10
Number of repeat ED visits
Number of repeat ED visits within 10 days of enrollment in the study
Measured: day 0-10
Number of tests ordered
Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.
Measured: day 0
Relative clinical charges
Relative clinical charges for ED visit in which a subject is enrolled in the study.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start3 Jan 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory PathogensStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care).
- Masking
- None (open label)
- Enrolment
- 913 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756753
- Sponsor's protocol ID
- 18-1492
- Acronym
- RAPID
- Status last verified
- Nov 2021
- First submitted
- 27 Nov 2018
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rao S, Lamb MM, Moss A, Mistry RD, Grice K, Ahmed W, Santos-Cantu D, Kitchen E, Patel C, Ferrari I, Dominguez SR. Effect of Rapid Respiratory Virus Testing on Antibiotic Prescribing Among Children Presenting to the Emergency Department With Acute Respiratory Illness: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2111836. doi: 10.1001/jamanetworkopen.2021.11836.
PubMed 34086034
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
- ClinicalTrials.gov ID
- NCT03756753
- Acronym / sponsor ID
- RAPID / 18-1492
- Conditions
- Respiratory Pathogens, Upper Respiratory Tract Illness, Lower Respiratory Tract Illness, Acute Respiratory Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 913 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid respiratory test in a pediatric emergency department. Participants will be randomized to the intervention group - results available to medical providers, or the control group- results not available to medical providers.
Detailed description
The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in children presenting to an Emergency Department setting with acute respiratory symptoms. The patient cohort will be children 1 month to 18 years of age presenting to the Children's Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population who are evaluated in an urgent care setting. All eligible participants will undergo a nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care). The investigators will compare the clinical outcomes between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care).
| Arm | Type | Receives |
|---|---|---|
| Intervention group- results known | Experimental | Diagnostic Test: Results available to providerProviders of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results |
| Control group- results not known | No intervention | –Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 1 month to < 18 years
- For children aged 1 month to 12 months of age: Presentation to the study sites with temperature > 37.8°C or cough, sore throat, runny nose or nasal congestion
- For children aged > 1 year to 18 years of age: Presentation to the study sites with influenza like illness, defined as temperature of >37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion
- Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for algorithm)
Key exclusion criteria (4 listed)
- Respiratory symptom duration > 14 days
- Previous enrollment in study within past 14 days
- Nurse-only visit
- Triage levels 1 and 2 based on Emergency Severity Index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Results available to providerResults of point of care testing are given to provider | Diagnostic test | Intervention group- results known |
Primary outcome
Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit
Time frame: day 0
Proportion of children who are prescribed an antibiotic at the ED visit.
7 secondary outcomes
Proportion of children treated with influenza antiviral at the ED visit
Time frame: day 0
Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit
Time frame: day 0
ED length of stay (hours)
Time frame: day 0
Days of Hospitalization
Time frame: day 0-10
Number of repeat ED visits
Time frame: day 0-10
Number of tests ordered
Time frame: day 0
Relative clinical charges
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 34086034Rao S, Lamb MM, Moss A, Mistry RD, Grice K, Ahmed W, Santos-Cantu D, Kitchen E, Patel C, Ferrari I, Dominguez SR. Effect of Rapid Respiratory Virus Testing on Antibiotic Prescribing Among Children Presenting to the Emergency Department With Acute Respiratory Illness: A Randomized Clinical Trial. JAMA Netw Open. 2021 Jun 1;4(6):e2111836. doi: 10.1001/jamanetworkopen.2021.11836.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Results available to provider in people with Respiratory Pathogens and Upper Respiratory Tract Illness, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03756753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.